- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07764367
Evaluation the Effects of Chewing Gum
11 augusti 2026 uppdaterad av: Pınar AKBAŞ, Karabuk University
Evaluating the Effects of Chewing Gum on Bowel Function, Postpartum Comfort and Satisfaction With Caesarean Birth: A Randomized Controlled Trial
This study was conducted as a randomized controlled trial to evaluate the effects of gum chewing in the early postpartum period on bowel function, postpartum comfort, and postpartum satisfaction in women.
The sample consisted of 66 women, 33 in the experimental group and 33 in the control group.
Data were collected using a pre-assessment form, a demographic information form, a bowel function monitoring form, a postpartum comfort scale, and a maternal satisfaction scale (cesarean delivery).
While the control group received no intervention other than standard postoperative care, the experimental group underwent gum chewing at 4, 6, and 8 hours postpartum.
Studieöversikt
Status
Avslutad
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
66
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Karabük, Turkiet (Türkiye), 78100
- Karabuk Training and Research Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- Women aged 18-45 years
- Women who underwent cesarean section under epidural or spinal anesthesia
Exclusion Criteria:
- Cesarean delivery under general anesthesia
- Jaw or oral membrane problems that may prevent chewing gum
- Any systemic or chronic disease
- Any mental or psychiatric illness
- History of chronic constipation
- Any communication problems, including mental, auditory, or visual impairments
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: chewing gum group
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In addition to routine post-cesarean care, women in the experimental group were given commercially available sugar-free, aspartame-free, sorbitol-free, xylitol-free, soft, and easy-to-chew gum to chew from the 4th hour post-operatively until they switched to Diet I. Since oral feeding was started at the 6th hour in the clinic where the study was conducted, women in the experimental group were given gum to chew at the 4th, 6th, and 8th hours after cesarean section, with each chewing session lasting between 15 and 30 minutes.
The women were instructed to chew their gum at the 6th hour post-cesarean and then drink water before starting oral feeding.
The gum used in one period was not repeated in the next period; a new pack of gum was used.
In this way, each woman chewed a total of 3 pieces of gum.
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Inget ingripande: no initiative
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Bowel motility (time to pass gas and stool)
Tidsram: 2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
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2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
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Maternal Satisfaction With Caesarean Birth Measured Using the Scale for Measuring Maternal Satisfaction-Caesarean Birth
Tidsram: 2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
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This measurement was evaluated using the Maternal Satisfaction Assessment Scale at Birth (Cesarean Birth).
Developed by Güngör and Beji (2009) to assess the experiences of women in the early postpartum period after cesarean delivery, this scale consists of 42 items on a 5-point Likert scale with 10 sub-dimensions: perception of the healthcare team, preparation for cesarean section, reassurance, participation in decision-making and information sharing, meeting the baby, postpartum care, hospital room, hospital facilities, respect for privacy, and meeting expectations.
Each item on the scale is scored between 1 (strongly disagree) and 5 (strongly agree).
Twelve items (8, 9, 10, 19, 20, 21, 22, 34, 35, 37, 40, 41) are reverse-scored.
The highest possible score is 210, and the lowest is 42.
As the score on the scale increases, the level of satisfaction also increases.
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2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
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Postpartum Comfort Level Measured Using the Postpartum Comfort Scale (PCS)
Tidsram: 2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
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This measurement was evaluated using the Postpartum Comfort Scale.
It is a scale developed by Karakaplan and Yıldız, based on Kolcaba's general comfort scale, and adapted for our country.
It was developed to evaluate the comfort of women who have had cesarean and vaginal deliveries.
The scale consists of 34 items with 3 sub-dimensions: sociocultural, psychospiritual, and physical, using a 5-point Likert scale.
Each item is scored between 1 (strongly disagree) and 5 (strongly agree).
The highest possible score on the scale is 170, and the lowest is 34.
The Postpartum Comfort Scale and sub-dimension scores are evaluated based on the total score, and as the score increases, the comfort level of the women increases.
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2 hours after cesarean section (baseline) and 44-48 hours after cesarean section (post-test).
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 december 2024
Primärt slutförande (Faktisk)
30 september 2025
Avslutad studie (Faktisk)
30 september 2025
Studieregistreringsdatum
Först inskickad
2 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
11 augusti 2026
Första postat (Faktisk)
13 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
13 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
11 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2024-KAEK-82
- KBÜBAP-25-YL-030 (Annat bidrag/finansieringsnummer: Karabük University Scientific Research Projects Coordination Unit)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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